AustralieFrV1, PascalFrancis, Corpus, bibRecord, 003268

A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients

Identifieur interne : 003268 ( PascalFrancis/Corpus ); précédent : 003267; suivant : 003269

A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients

Auteurs : X. Pivot ; P. Koralewski ; J. L. Hidalgo ; A. Chan ; A. Goncalves ; G. Schwartsmann ; S. Assadourian ; J. P. Lotz

Source :

Annals of oncology [ 0923-7534 ] ; 2008.

RBID : Pascal:08-0479465

Descripteurs français

Pascal (Inist)
- Etude multicentrique, Homme, Essai clinique phase II, Traitement, Perfusion, Dérivé du taxane, Résistance, Stade avancé, Métastase, Cancer du sein, Chimiothérapie.

English descriptors

KwdEn :
- Advanced stage, Breast cancer, Chemotherapy, Human, Metastasis, Multicenter study, Perfusion, Phase II trial, Resistance, Taxane derivatives, Treatment.

Abstract

Background: XRP6258 is a novel taxoid with a low affinity for P-glycoprotein. This multicenter phase II study assessed the activity of XRP6258 in the treatment of taxane-resistant metastatic breast cancer (MBC). Patients and methods: XRP6258 was administered as a 1-h i.v. infusion every 3 weeks at 20 mg/m² (then, in the absence of severe toxicity, at 25 mg/m² from cycle 2). The primary end point was the objective response rate (ORR) assessed according to response evaluation criteria in solid tumours (RECIST) guidelines. Results: Seventy-one patients were enrolled. The median relative dose intensity was 0.98. The ORR was 14% (two complete, eight partial responses). Eighteen patients (25%) had stable disease of >3 months duration. At a median follow-up of 20.0 months, the median time to progression was 2.7 months, and the median overall survival 12.3 months. The most common grade 3/4 adverse events (AEs) were neutropenia (73%) and leucopenia (55%), with a low febrile neutropenia rate (3%) and infrequent grade 3/4, treatment-related, non-hematological AEs (<5% patients for any AE). Two deaths were reported, one related to study drug and one to unknown cause. Conclusions: XRP6258 was active and well tolerated in this group of MBC patients with taxane-resistant disease. These results support the further clinical development of this agent.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A11	`02`	`1`		`@1 KORALEWSKI (P.)`
A11	`03`	`1`		`@1 HIDALGO (J. L.)`
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C01	`01`		`ENG`	@0 Background: XRP6258 is a novel taxoid with a low affinity for P-glycoprotein. This multicenter phase II study assessed the activity of XRP6258 in the treatment of taxane-resistant metastatic breast cancer (MBC). Patients and methods: XRP6258 was administered as a 1-h i.v. infusion every 3 weeks at 20 mg/m² (then, in the absence of severe toxicity, at 25 mg/m² from cycle 2). The primary end point was the objective response rate (ORR) assessed according to response evaluation criteria in solid tumours (RECIST) guidelines. Results: Seventy-one patients were enrolled. The median relative dose intensity was 0.98. The ORR was 14% (two complete, eight partial responses). Eighteen patients (25%) had stable disease of >3 months duration. At a median follow-up of 20.0 months, the median time to progression was 2.7 months, and the median overall survival 12.3 months. The most common grade 3/4 adverse events (AEs) were neutropenia (73%) and leucopenia (55%), with a low febrile neutropenia rate (3%) and infrequent grade 3/4, treatment-related, non-hematological AEs (<5% patients for any AE). Two deaths were reported, one related to study drug and one to unknown cause. Conclusions: XRP6258 was active and well tolerated in this group of MBC patients with taxane-resistant disease. These results support the further clinical development of this agent.
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Format Inist (serveur)

NO :	PASCAL 08-0479465 INIST
ET :	A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients
AU :	PIVOT (X.); KORALEWSKI (P.); HIDALGO (J. L.); CHAN (A.); GONCALVES (A.); SCHWARTSMANN (G.); ASSADOURIAN (S.); LOTZ (J. P.)
AF :	Department of Medical Oncology, University Hospital Jean Minjoz, Besançon; Institut National de la Santé et de la Recherche Médicale, Unit 645/Besançon/France (1 aut.); Rydygier Memorial Hospital, os. Zlotej Jesieni 1/31-826 Krakow/Pologne (2 aut.); Clinical Oncology Institution and Research/Mendoza/Argentine (3 aut.); Department of Medical Oncology, Mount Hospital/Perth/Australie (4 aut.); Department of Medical Oncology, Institut Paoli Calmettes, UMR599 Inserm, Université de la Méditerranée Marseille/France (5 aut.); Department of Medical Oncology, Federal Univ/Porto Alegre/Brésil (6 aut.); Department of Oncology development, Sanofi-Aventis/Antony/France (7 aut.); Department of Medical Oncology, Hopital Tenon/Paris/France (8 aut.)
DT :	Publication en série; Niveau analytique
SO :	Annals of oncology; ISSN 0923-7534; Royaume-Uni; Da. 2008; Vol. 19; No. 9; Pp. 1547-1552; Bibl. 28 ref.
LA :	Anglais
EA :	Background: XRP6258 is a novel taxoid with a low affinity for P-glycoprotein. This multicenter phase II study assessed the activity of XRP6258 in the treatment of taxane-resistant metastatic breast cancer (MBC). Patients and methods: XRP6258 was administered as a 1-h i.v. infusion every 3 weeks at 20 mg/m² (then, in the absence of severe toxicity, at 25 mg/m² from cycle 2). The primary end point was the objective response rate (ORR) assessed according to response evaluation criteria in solid tumours (RECIST) guidelines. Results: Seventy-one patients were enrolled. The median relative dose intensity was 0.98. The ORR was 14% (two complete, eight partial responses). Eighteen patients (25%) had stable disease of >3 months duration. At a median follow-up of 20.0 months, the median time to progression was 2.7 months, and the median overall survival 12.3 months. The most common grade 3/4 adverse events (AEs) were neutropenia (73%) and leucopenia (55%), with a low febrile neutropenia rate (3%) and infrequent grade 3/4, treatment-related, non-hematological AEs (<5% patients for any AE). Two deaths were reported, one related to study drug and one to unknown cause. Conclusions: XRP6258 was active and well tolerated in this group of MBC patients with taxane-resistant disease. These results support the further clinical development of this agent.
CC :	002B02R; 002B20E02
FD :	Etude multicentrique; Homme; Essai clinique phase II; Traitement; Perfusion; Dérivé du taxane; Résistance; Stade avancé; Métastase; Cancer du sein; Chimiothérapie
FG :	Tumeur maligne; Cancer; Pathologie de la glande mammaire; Pathologie du sein
ED :	Multicenter study; Human; Phase II trial; Treatment; Perfusion; Taxane derivatives; Resistance; Advanced stage; Metastasis; Breast cancer; Chemotherapy
EG :	Malignant tumor; Cancer; Mammary gland diseases; Breast disease
SD :	Estudio multicéntrico; Hombre; Ensayo clínico fase II; Tratamiento; Perfusión; Taxane derivado; Resistencia; Estadio avanzado; Metástasis; Cáncer del pecho; Quimioterapia
LO :	INIST-22429.354000185788650050
ID :	08-0479465

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Pascal:08-0479465

Le document en format XML

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<front><div type="abstract" xml:lang="en">Background: XRP6258 is a novel taxoid with a low affinity for P-glycoprotein. This multicenter phase II study assessed the activity of XRP6258 in the treatment of taxane-resistant metastatic breast cancer (MBC). Patients and methods: XRP6258 was administered as a 1-h i.v. infusion every 3 weeks at 20 mg/m<sup>2</sup>
 (then, in the absence of severe toxicity, at 25 mg/m<sup>2</sup>
 from cycle 2). The primary end point was the objective response rate (ORR) assessed according to response evaluation criteria in solid tumours (RECIST) guidelines. Results: Seventy-one patients were enrolled. The median relative dose intensity was 0.98. The ORR was 14% (two complete, eight partial responses). Eighteen patients (25%) had stable disease of >3 months duration. At a median follow-up of 20.0 months, the median time to progression was 2.7 months, and the median overall survival 12.3 months. The most common grade 3/4 adverse events (AEs) were neutropenia (73%) and leucopenia (55%), with a low febrile neutropenia rate (3%) and infrequent grade 3/4, treatment-related, non-hematological AEs (<5% patients for any AE). Two deaths were reported, one related to study drug and one to unknown cause. Conclusions: XRP6258 was active and well tolerated in this group of MBC patients with taxane-resistant disease. These results support the further clinical development of this agent.</div>
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<fA11 i1="04" i2="1"><s1>CHAN (A.)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>GONCALVES (A.)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>SCHWARTSMANN (G.)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>ASSADOURIAN (S.)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>LOTZ (J. P.)</s1>
</fA11>
<fA14 i1="01"><s1>Department of Medical Oncology, University Hospital Jean Minjoz, Besançon; Institut National de la Santé et de la Recherche Médicale, Unit 645</s1>
<s2>Besançon</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Rydygier Memorial Hospital, os. Zlotej Jesieni 1</s1>
<s2>31-826 Krakow</s2>
<s3>POL</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Clinical Oncology Institution and Research</s1>
<s2>Mendoza</s2>
<s3>ARG</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Department of Medical Oncology, Mount Hospital</s1>
<s2>Perth</s2>
<s3>AUS</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Department of Medical Oncology, Institut Paoli Calmettes, UMR599 Inserm, Université de la Méditerranée Marseille</s1>
<s3>FRA</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Department of Medical Oncology, Federal Univ</s1>
<s2>Porto Alegre</s2>
<s3>BRA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Department of Oncology development, Sanofi-Aventis</s1>
<s2>Antony</s2>
<s3>FRA</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Department of Medical Oncology, Hopital Tenon</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA20><s1>1547-1552</s1>
</fA20>
<fA21><s1>2008</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>22429</s2>
<s5>354000185788650050</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2008 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>28 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>08-0479465</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>Annals of oncology</s0>
</fA64>
<fA66 i1="01"><s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>Background: XRP6258 is a novel taxoid with a low affinity for P-glycoprotein. This multicenter phase II study assessed the activity of XRP6258 in the treatment of taxane-resistant metastatic breast cancer (MBC). Patients and methods: XRP6258 was administered as a 1-h i.v. infusion every 3 weeks at 20 mg/m<sup>2</sup>
 (then, in the absence of severe toxicity, at 25 mg/m<sup>2</sup>
 from cycle 2). The primary end point was the objective response rate (ORR) assessed according to response evaluation criteria in solid tumours (RECIST) guidelines. Results: Seventy-one patients were enrolled. The median relative dose intensity was 0.98. The ORR was 14% (two complete, eight partial responses). Eighteen patients (25%) had stable disease of >3 months duration. At a median follow-up of 20.0 months, the median time to progression was 2.7 months, and the median overall survival 12.3 months. The most common grade 3/4 adverse events (AEs) were neutropenia (73%) and leucopenia (55%), with a low febrile neutropenia rate (3%) and infrequent grade 3/4, treatment-related, non-hematological AEs (<5% patients for any AE). Two deaths were reported, one related to study drug and one to unknown cause. Conclusions: XRP6258 was active and well tolerated in this group of MBC patients with taxane-resistant disease. These results support the further clinical development of this agent.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B02R</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B20E02</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Etude multicentrique</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Multicenter study</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Estudio multicéntrico</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Homme</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Human</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Hombre</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Essai clinique phase II</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Phase II trial</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Ensayo clínico fase II</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Traitement</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Treatment</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Perfusion</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Perfusion</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Perfusión</s0>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Dérivé du taxane</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Taxane derivatives</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Taxane derivado</s0>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Résistance</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Resistance</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Resistencia</s0>
<s5>07</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Stade avancé</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Advanced stage</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Estadio avanzado</s0>
<s5>08</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Métastase</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Metastasis</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Metástasis</s0>
<s5>09</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Cancer du sein</s0>
<s2>NM</s2>
<s5>10</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Breast cancer</s0>
<s2>NM</s2>
<s5>10</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Cáncer del pecho</s0>
<s2>NM</s2>
<s5>10</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Chimiothérapie</s0>
<s5>11</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Chemotherapy</s0>
<s5>11</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Quimioterapia</s0>
<s5>11</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Tumeur maligne</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Malignant tumor</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Tumor maligno</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Cáncer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Pathologie de la glande mammaire</s0>
<s2>NM</s2>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Mammary gland diseases</s0>
<s2>NM</s2>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Glándula mamaria patología</s0>
<s2>NM</s2>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Pathologie du sein</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Breast disease</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Seno patología</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fN21><s1>308</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
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<server><NO>PASCAL 08-0479465 INIST</NO>
<ET>A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients</ET>
<AU>PIVOT (X.); KORALEWSKI (P.); HIDALGO (J. L.); CHAN (A.); GONCALVES (A.); SCHWARTSMANN (G.); ASSADOURIAN (S.); LOTZ (J. P.)</AU>
<AF>Department of Medical Oncology, University Hospital Jean Minjoz, Besançon; Institut National de la Santé et de la Recherche Médicale, Unit 645/Besançon/France (1 aut.); Rydygier Memorial Hospital, os. Zlotej Jesieni 1/31-826 Krakow/Pologne (2 aut.); Clinical Oncology Institution and Research/Mendoza/Argentine (3 aut.); Department of Medical Oncology, Mount Hospital/Perth/Australie (4 aut.); Department of Medical Oncology, Institut Paoli Calmettes, UMR599 Inserm, Université de la Méditerranée Marseille/France (5 aut.); Department of Medical Oncology, Federal Univ/Porto Alegre/Brésil (6 aut.); Department of Oncology development, Sanofi-Aventis/Antony/France (7 aut.); Department of Medical Oncology, Hopital Tenon/Paris/France (8 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Annals of oncology; ISSN 0923-7534; Royaume-Uni; Da. 2008; Vol. 19; No. 9; Pp. 1547-1552; Bibl. 28 ref.</SO>
<LA>Anglais</LA>
<EA>Background: XRP6258 is a novel taxoid with a low affinity for P-glycoprotein. This multicenter phase II study assessed the activity of XRP6258 in the treatment of taxane-resistant metastatic breast cancer (MBC). Patients and methods: XRP6258 was administered as a 1-h i.v. infusion every 3 weeks at 20 mg/m<sup>2</sup>
 (then, in the absence of severe toxicity, at 25 mg/m<sup>2</sup>
 from cycle 2). The primary end point was the objective response rate (ORR) assessed according to response evaluation criteria in solid tumours (RECIST) guidelines. Results: Seventy-one patients were enrolled. The median relative dose intensity was 0.98. The ORR was 14% (two complete, eight partial responses). Eighteen patients (25%) had stable disease of >3 months duration. At a median follow-up of 20.0 months, the median time to progression was 2.7 months, and the median overall survival 12.3 months. The most common grade 3/4 adverse events (AEs) were neutropenia (73%) and leucopenia (55%), with a low febrile neutropenia rate (3%) and infrequent grade 3/4, treatment-related, non-hematological AEs (<5% patients for any AE). Two deaths were reported, one related to study drug and one to unknown cause. Conclusions: XRP6258 was active and well tolerated in this group of MBC patients with taxane-resistant disease. These results support the further clinical development of this agent.</EA>
<CC>002B02R; 002B20E02</CC>
<FD>Etude multicentrique; Homme; Essai clinique phase II; Traitement; Perfusion; Dérivé du taxane; Résistance; Stade avancé; Métastase; Cancer du sein; Chimiothérapie</FD>
<FG>Tumeur maligne; Cancer; Pathologie de la glande mammaire; Pathologie du sein</FG>
<ED>Multicenter study; Human; Phase II trial; Treatment; Perfusion; Taxane derivatives; Resistance; Advanced stage; Metastasis; Breast cancer; Chemotherapy</ED>
<EG>Malignant tumor; Cancer; Mammary gland diseases; Breast disease</EG>
<SD>Estudio multicéntrico; Hombre; Ensayo clínico fase II; Tratamiento; Perfusión; Taxane derivado; Resistencia; Estadio avanzado; Metástasis; Cáncer del pecho; Quimioterapia</SD>
<LO>INIST-22429.354000185788650050</LO>
<ID>08-0479465</ID>
</server>
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A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients

A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients

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